公司主要产品持续推进中，加速开拓国际市场。根据公司23 年年报，HT Infinity?支架系统于23 年6 月获批；23 年9 月，冠脉棘突球囊扩张导管获批；新一代后扩张球囊和新一代预扩张球囊先后获得国家药监局医疗器械注册证以及美国FDA（510k）认证；全球首款自膨式颅内药物涂层支架系统已通过国家药监局《创新医疗器械特别审查程序》审查；密网支架于24 年提交创新通道审批。公司接受美国FDA 美国市场准入的现场检查，目前FDA 各项审核工作仍在有序进行中。Core views:
The company's 23-year performance was in line with expectations, and net profit to mother was drastically reduced. According to the company's annual report for the year 23, the company achieved revenue of 343 million yuan (YOY +77.99%), of which revenue from coronary and neurological intervention businesses increased 99.1% and 60.59% year-on-year respectively; net profit to mother -40 million yuan, a loss of 123 million yuan over the same period last year; and gross profit margin of 58.92% (YOY-4.2pp). According to Wind, the company achieved revenue of 91 million yuan (YOY +24.46%) and net profit to mother of 0.2 billion yuan (YOY +115.42%) in 24Q1, mainly due to a combination of factors such as a 24.46% year-on-year increase in revenue, an 11.61% year-on-year increase in operating costs, and a 398.86% year-on-year increase in non-recurring profit and loss.
Both cost sides declined. According to Wind, the company's 23-year sales expense ratio was 18.41% (Yoy-10.23PP), mainly due to a significant increase in operating income and an increase in marketing team expenses; 27.55% (YOY -34.43%), mainly due to the combined effects of factors such as increased service fees and share payment costs; and the R&D expense ratio of 33.24% (YOY-45.99PP), mainly due to the reduction in R&D projects and the entry of some R&D projects into a critical milestone.
The company's main products continue to be promoted to accelerate the development of international markets. According to the company's 23rd annual report, HT Infinity? The stent system was approved in June '23; in September '23, the coronary spinous balloon dilatation catheter was approved; new-generation post-dilatation balloons and new-generation pre-dilated balloons obtained the National Drug Administration's medical device registration certificate and US FDA (510k) certification; the world's first self-inflating intracranial drug coated stent system has passed the National Drug Administration's “Special Examination Procedure for Innovative Medical Devices”; the dense net stent was submitted for approval through the Innovation Channel in '24. The company underwent on-site inspection by the US FDA for entry into the US market. Currently, all FDA audits are still being carried out in an orderly manner.
Profit forecasting and investment advice. The corresponding revenue for 24-26 is estimated to be 500 million yuan, 7.33 billion yuan, and 1,086 million yuan, respectively. Taking into account the company's position in the industry and business growth, the company was given a 24-year PS10X (considering that some of the company's products are currently in the development and new product introduction stage, so the PS valuation is more reasonable), with a corresponding reasonable value of 12.21 yuan/share, giving it a “buy” rating.
Risk warning. Procurement policy risks, new product launches falling short of expectations, and risk of continued losses.
